Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04601207
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2020-07-29
Brief Title:
A Study Investigating the Bioavailability of CBD and THC in an Emulsion Product in a Healthy Population
Sponsor:
New Age Ventures LLC
Organization:
New Age Ventures LLC
Study Overview
Official Title:
A Single-center Randomized Double-blind Comparator-controlled Parallel Study Investigating the Bioavailability of Cannabidiol and Δ9-Tetrahydrocannabinol in an Emulsion Product in a Healthy Population
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to investigate the bioavailability of Cannabidiol CBD and Tetrahydrocannabinol THC in an emulsion product against a comparator product Thirty-two participants will be randomized into a single-center double-blind parallel trial Participants will be dosed in clinic and blood and urine samples will be taken over a 12-hour period Blood and urine samples will also be collected for 48 hours post-dose at check-in visits Questionnaires regarding drug effects and cognitive function will also be completed following each blood sampling Participants who consumed the comparator product will be asked to return to the clinic following a wash-out period of at least 45 days to consume the emulsion product in-clinic and complete questionnaires at the same specified time points over a 12-hour period
Detailed Description:
The use of marijuana or cannabis for medicinal purposes is deeply rooted in history and medicinal preparations from Cannabis indica and C sativa have been used for almost 5000 years for treating nausea inflammation vomiting and pain However the major lipophilic cannabinoids out of 60 terpenophenolic compounds that cause these effects were not identified until the early 20th century Sativex dronabinol and nabilone synthetic or similar to cannabinoids are the only currently approved cannabis derived medicinal products in the United States and Canada for different conditions such as nausea and vomiting associated with cancer multiple sclerosis intractable cancer pain etc Controversies regarding legal medicinal and ethical use of cannabis have increasingly placed this plant in the spotlight in recent years Although the use of cannabis fell from favor to fear in the early 1900s a widespread support for its use for medicinal purposes has been on the rise in several countries across the world
Cannabidiol CBD a cannabinoid constituent of cannabis plants possesses anxiolytic antipsychotic antiemetic and anti-inflammatory properties without exhibiting the psychoactive effects of Δ9-tetrahydrocannabinol Δ9-THC the other major cannabinoid from the same plant Δ9-THC and CBD are biosynthesized as Δ9-tetrahydrocannabinolic acid and cannabidiolic acid from the common precursor olivetol Both Δ9-THC and CBD exert their effects by interacting with the G protein-coupled cannabinoid receptors GPCRs CB1 and CB2 with varying affinities While CB1 receptors are expressed in large quantities in the brain and regions central nervous system and in lower amounts in peripheral tissues the less studied CB2 receptors have been identified to be localized to immune cells tonsils and the spleen The CB1 receptors have been identified to play significant roles in pain perception memory motor regulation appetite mood and sleep whereas the CB2 receptors have been linked with anti-inflammation pain reduction and reducing tissue damage Physiologically upon activation by the endocannabinoids like anandamide and 2-arachidonylglycerol 2-AG which are short lived CB1 and CB2 trigger a downstream cascade of events that mediate homeostasis and healthy functioning In contrast the phytocannabinoids Δ9-THC and CBD that directly or indirectly interact with CB1 and CB2 with varying affinities modulate the activities of these receptors for prolonged durations
Δ9-THC is the major psychoactive cannabinoid and mimics the action of the endogenous cannabinoid receptor ligands anandamide and 2-AG by activating both CB1 and CB2 receptors Due to its binding to CB1 receptors which are specifically present in the central nervous system in areas associated with pain eg Spinal trigeminal nucleus amygdala basal ganglia and periaqueductal gray Δ9-THC possesses antinociceptive activity and is hence used as an analgesic agent in certain pain medications In addition Δ9-THC has also been shown to be effective in the treatment of glaucoma nausea chronic pain multiple sclerosis epilepsy and inflammation in several pre-clinical and clinical studies However Δ9-THC abuse is a global concern and due to the behavioural and psychological dependence Δ9-THC has remained a subject of controversy and a largely unproved therapy with limited studies establishing its benefit-to-risk ratio safety and efficacy for different indications
CBD which is the non psychoactive phytocannabinoid and can hence be a promising therapeutic has gained increasing attention in the recent past Previous studies have shown that CBD is a promising potential therapeutic for various disorders of the central nervous system including anxiety epilepsy schizophrenia Parkinsons disease Alzhiemers disease multiple sclerosis and many more Unlike Δ9-THC CBD does not activate CB1 and CB2 and instead blocks the cannabinoids that activate these receptors by a complex mechanism Several groups have proposed that this activity not only results in the non-psychotropic effects exhibited by CBD but may also account for ameliorating some of the psychotropic effects shown by Δ9-THC In addition by lowering the psychoactivity of Δ9-THC CBD may also potentiate some of Δ9-THCs benefits by enhancing its tolerability and widening its therapeutic window CBD can also inhibit or delay the reuptake and hydrolysis of the endocannabinoids like anandamide and adenosine CBD has also been hypothesized to interact with several other non-endocannabinoid signaling systems such as serotonin receptors vanilloid receptors GPR-55 orphan receptors peroxisome proliferator activated receptors PPARs making it a multi-target drug In addition to these activities the polyphenolic ring in CBD also results in it being a potent antioxidant All these results have prompted the exploration of the therapeutic potential of CBD for a range of neuropsychiatric as well as inflammatory disorders
Several groups have attempted to study the pharmacokinetics and pharmacodynamics of CBD and Δ9-THC It is generally accepted in drug research that lipophilicity promotes the passage of molecules across cellular barriers and therefore the most lipophilic compounds will have greatest intestinal absorption Due to the lipophilicity of cannabinoids smoking results in the fastest absorption of CBD and Δ9-THC however the half-life of CBD in humans was found to be between 18-33 h upon intravenous injection 27-35 h upon smoking and 2-5 days upon oral administration Bioavailability of oral and smoked CBD in humans was found to be around 6 and 31 respectively and bioavailability of oral and smoked Δ9-THC is shown to be 4-12 and 10-27 respectively Other studies have previously determined the time to achieve peak plasma concentration tmax as 15- 4 h for different doses of CBD and 1-2 h for different doses of Δ9-THC This single-center randomized double-blind comparator-controlled parallel study will investigate the bioavailability of CBD and Δ9-THC in the test product- SolutechTM - TC10 manufactured by New Age Ventures LLC in a healthy population
Cannabidiol CBD a cannabinoid constituent of cannabis plants possesses anxiolytic antipsychotic antiemetic and anti-inflammatory properties without exhibiting the psychoactive effects of Δ9-tetrahydrocannabinol Δ9-THC the other major cannabinoid from the same plant Δ9-THC and CBD are biosynthesized as Δ9-tetrahydrocannabinolic acid and cannabidiolic acid from the common precursor olivetol Both Δ9-THC and CBD exert their effects by interacting with the G protein-coupled cannabinoid receptors GPCRs CB1 and CB2 with varying affinities While CB1 receptors are expressed in large quantities in the brain and regions central nervous system and in lower amounts in peripheral tissues the less studied CB2 receptors have been identified to be localized to immune cells tonsils and the spleen The CB1 receptors have been identified to play significant roles in pain perception memory motor regulation appetite mood and sleep whereas the CB2 receptors have been linked with anti-inflammation pain reduction and reducing tissue damage Physiologically upon activation by the endocannabinoids like anandamide and 2-arachidonylglycerol 2-AG which are short lived CB1 and CB2 trigger a downstream cascade of events that mediate homeostasis and healthy functioning In contrast the phytocannabinoids Δ9-THC and CBD that directly or indirectly interact with CB1 and CB2 with varying affinities modulate the activities of these receptors for prolonged durations
Δ9-THC is the major psychoactive cannabinoid and mimics the action of the endogenous cannabinoid receptor ligands anandamide and 2-AG by activating both CB1 and CB2 receptors Due to its binding to CB1 receptors which are specifically present in the central nervous system in areas associated with pain eg Spinal trigeminal nucleus amygdala basal ganglia and periaqueductal gray Δ9-THC possesses antinociceptive activity and is hence used as an analgesic agent in certain pain medications In addition Δ9-THC has also been shown to be effective in the treatment of glaucoma nausea chronic pain multiple sclerosis epilepsy and inflammation in several pre-clinical and clinical studies However Δ9-THC abuse is a global concern and due to the behavioural and psychological dependence Δ9-THC has remained a subject of controversy and a largely unproved therapy with limited studies establishing its benefit-to-risk ratio safety and efficacy for different indications
CBD which is the non psychoactive phytocannabinoid and can hence be a promising therapeutic has gained increasing attention in the recent past Previous studies have shown that CBD is a promising potential therapeutic for various disorders of the central nervous system including anxiety epilepsy schizophrenia Parkinsons disease Alzhiemers disease multiple sclerosis and many more Unlike Δ9-THC CBD does not activate CB1 and CB2 and instead blocks the cannabinoids that activate these receptors by a complex mechanism Several groups have proposed that this activity not only results in the non-psychotropic effects exhibited by CBD but may also account for ameliorating some of the psychotropic effects shown by Δ9-THC In addition by lowering the psychoactivity of Δ9-THC CBD may also potentiate some of Δ9-THCs benefits by enhancing its tolerability and widening its therapeutic window CBD can also inhibit or delay the reuptake and hydrolysis of the endocannabinoids like anandamide and adenosine CBD has also been hypothesized to interact with several other non-endocannabinoid signaling systems such as serotonin receptors vanilloid receptors GPR-55 orphan receptors peroxisome proliferator activated receptors PPARs making it a multi-target drug In addition to these activities the polyphenolic ring in CBD also results in it being a potent antioxidant All these results have prompted the exploration of the therapeutic potential of CBD for a range of neuropsychiatric as well as inflammatory disorders
Several groups have attempted to study the pharmacokinetics and pharmacodynamics of CBD and Δ9-THC It is generally accepted in drug research that lipophilicity promotes the passage of molecules across cellular barriers and therefore the most lipophilic compounds will have greatest intestinal absorption Due to the lipophilicity of cannabinoids smoking results in the fastest absorption of CBD and Δ9-THC however the half-life of CBD in humans was found to be between 18-33 h upon intravenous injection 27-35 h upon smoking and 2-5 days upon oral administration Bioavailability of oral and smoked CBD in humans was found to be around 6 and 31 respectively and bioavailability of oral and smoked Δ9-THC is shown to be 4-12 and 10-27 respectively Other studies have previously determined the time to achieve peak plasma concentration tmax as 15- 4 h for different doses of CBD and 1-2 h for different doses of Δ9-THC This single-center randomized double-blind comparator-controlled parallel study will investigate the bioavailability of CBD and Δ9-THC in the test product- SolutechTM - TC10 manufactured by New Age Ventures LLC in a healthy population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None